Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT07234058
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pleural Mesotheliomas

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    350mg every 3 weeks for up to 24 months.
  • Fianlimab — DRUG
    1600mg every 3 weeks for up to 24 months.
  • Pemetrexed (Alimta) — DRUG
    500 mg/m² every 3 weeks for 6 cycles.
  • Cisplatin — DRUG
    75 mg/m² every 3 weeks for 6 cycles.
  • Carboplatin (AUC 5) — DRUG
    AUC 5 (recommended maximum dose of 800 mg) every 3 weeks for 6 cycles.

Study Details

This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm. Approximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM. Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum. Once the patient discontinues study treatment, the treatment period will end and the patient will enter the follow-up period. No cross-over is allowed between arms.

Key Dates

First listed
Nov 18, 2025
Start date
Apr 2, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A: cemplimab + chemotherapy
    cemplimab 350mg administered every 3 weeks for up to 24 months, with pemetrexed 500 mg/m² + platinum salt (cisplatin 75 mg/m² or carboplatin AUC 5) for 6 cycles of 21 days.
  • Experimental: Arm B: cemplimab + fianlimab + chemotherapy
    cemplimab 350mg and fianlimab 1600mg administered every 3 weeks for up to 24 months, with pemetrexed 500 mg/m² + platinum salt (cisplatin 75 mg/m² or carboplatin AUC 5) for 6 cycles of 21 days.

Primary Outcome Measure

To evaluate the activity of the combination of double immunotherapy anti-LAG3+ anti-PD-1 and pemetrexed+platinum chemotherapy [ Time Frame: 6 months after randomisation. ]

Central Contacts